Atmos
The device is a microscope intended to give a magnified illuminated spacial view on human tissue for diagnostic and treatment purposes. It also can be used for surgical purposes.
11manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
| Hefei MAX ACT Medical Equipment Co., Ltd. | Hefei | Anhui | Manufacturer | 1 |
| Shanghai Eder Medical Technology Inc. | Shanghai | Shanghai | Manufacturer | 1 |
| Suzhou Semorr Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Atmos Medizintechnik Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | FSO |
| Device type | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| i View 21 PRO | In distribution | |
| i View 31 PRO | In distribution | |
| i View 21 | In distribution | |
| i View 31 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 130 |
| MaxView System – Lateral Set | Viseon, Inc. | 7 |
| S100 / Opmi pico | Carl Zeiss Meditec Inc | 6 |
| S7 / Opmi PROergo | Carl Zeiss Meditec Inc | 6 |
| Aesculap | Aesculap AG | 4 |
| MaxView™ System – Lateral Set with Illumination | Viseon, Inc. | 3 |
| S7 / Opmi Sensera | Carl Zeiss Meditec Inc | 3 |
| Medical Microscope | Denjoy Dental Co., Ltd. | 3 |
| RoboticScope | Bhs Intl., Inc. | 2 |
| Rols Reinverter – Leica+ | Volk Optical Inc. | 2 |
| Rols Reinverter – Zeiss + | Volk Optical Inc. | 2 |
| MaxView 4K, Lateral Imager | Viseon, Inc. | 2 |
Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.